Feds Take Action Against Tylenol-Maker McNeil

The U.S. Food and Drug Administration and the Justice Department took action against McNeil-PPC today, filing a proposed consent decree for failing to follow good manufacturing practices in the two-year wake of massive recalls of popular over-the-counter drugs including Tylenol, Rolaids, Benadryl and Motrin, the agencies said.

In a statement sent to Consumer Ally, McNeil said it has already been putting remediation programs in place in a plan it gave to the FDA in July 2010.

"McNeil believes that the terms of the Consent Decree recognize the progress made in remediation efforts to date, and are consistent with the commitments the company has made," McNeil said in the statement. The consent decree was agreed to by McNeil and governs the operations at three plants.The proposed decree governs the fate of two plants in Fort Washington and Lancaster, both in Pennsylvania, and one in Las Piedras, Puerto Rico. McNeil will be allowed to continue to run the Las Piedras and Lancaster plants. The Fort Washington plant has been closed since April 2010. The company also has to work with an independent expert to inspect the plants and recommend changes to be included in a FDA-approved remediation plan.

McNeil said it expected the consent decree to direct the three plants' operations for at least five years after the remediation plan is put in place.

The FDA said the decree also requires McNeil to destroy all recalled drugs that came from the three plants since December 2009. If McNeil violates the decree, the FDA could order the company to stop manufacturing, recall products or even fine it up to $10 million a year.

"This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, in a statement.

The decree has to be approved by a U.S. District Court judge in the Eastern District of Pennsylvania where it was filed.